Intraurethral device and method

ABSTRACT

A device and method for treating female urinary incontinence is provided. A device in accordance with the invention includes a sheath having a distal portion, a proximal portion, and a lumen extending therebetween. A distal member is elastically hinged to the distal portion of the sheath. A flow control valve unit is disposed within a lumen of the sheath. The distal member may be urged into axial alignment with the sheath, and the device may be inserted into a female urethra. Once the device is inserted sufficiently distally into the female urethra, the distal member will return to a position which is not in axial alignment with the sheath.

FIELD OF THE INVENTION

[0001] The present invention relates generally to devices and methodsfor treating female urinary incontinence. More particularly, the presentinvention relates to intraurethral devices and methods for controllingurine flow.

BACKGROUND OF THE INVENTION

[0002] Female urinary incontinence is a common medical condition, havingwidespread economic and social ramifications. The difficulty andembarrassment associated with urinary incontinence often causes theaffected person to limit her social activities. In some cases, pads ordiapers are used to absorb the uncontrolled seepage of urine. Theseabsorbent items must be changed frequently, creating. an ongoingeconomic burden. The wearing of absorbent undergarments may alsorestrict the type or style of clothing which the patient may wear. Moreseriously, skin irritation and other hygienic difficulties often resultfrom the lingering presence of captured urine against tender urogenitaltissues.

[0003] An additional method of treating urinary incontinence is the useof bladder flow control devices, sometimes referred to as artificialsphincters or prosthetic urethral valves. A bladder flow control devicemay be positioned in the. urethra of a patient to control the flow ofurine out of the bladder. It is desirable for the placement of thebladder flow control apparatus in the urethra to be performed easily andnon-surgically. Once the bladder flow control device is placed, it isdesirable that it be safely and securely retained in the urethra.Optimally, the device surfaces which contact the human body. will beformed of biocompatible materials, to lessen chances of inflammation inpatients.

SUMMARY OF THE INVENTION

[0004] The present invention relates generally to devices and methodsfor treating female urinary incontinence. More particularly, the presentinvention relates to an intraurethral device including a sheath having adistal portion and a proximal portion. The sheath includes a proximalretainer disposed proximate its proximal end. The proximal retainerserves to prevent distal motion of the sheath into the patient by lyingagainst the urethral labia. The sheath further includes a sheath walldefining a central lumen. A flow control valve unit is disposed in thelumen of the sheath.

[0005] An intraurethral device in accordance with the present invention,further includes a distal member having a distal tip and a proximalportion. The proximal portion of the distal member is fixed to thedistal portion of the sheath by a linking means. In one embodiment ofthe present invention, the linking means includes an elastomer hinge.When the elastomer hinge is in a natural, undeformed state, the centralaxis of the distal member of the intraurethral device is positioned atan angle to the central axis of the sheath. The distal member of theintraurethral device may be urged into axial alignment with the sheathby deforming the elastomer hinge.

[0006] In a presently preferred method in accordance with the presentinvention, the distal member is urged into axial alignment with thesheath during insertion of the intraurethral device into the urethra ofa patient. In this presently preferred method, the intraurethral deviceis inserted into the urethra of the patient until the distal member isfree to assume a misaligned position. In this misaligned position, theelastomer hinge assumes its natural, undeformed state. When the distalmember of the intraurethal device assumes this misaligned position, thedistal member serves to prevent proximal motion of the sheath out of thepatient by contacting the bladder floor. Distal motion of the sheathinto the patient is prohibited by the proximal retainer disposed at theproximal end of the sheath. In this manner, the intraurethral device isheld within the urethra by the distal member and the proximal retaineracting at opposite ends of the urethra.

[0007] An insertion tool is also provided. The insertion tool includes ashaft having a distal end and a proximal end. The distal end of theshaft is adapted to selectively form a connection with a proximal end ofthe flow control valve unit disposed in the lumen of the sheath. Theshaft of the insertion tool provides a convenient location to grasp theassembly. The use of an insertion tool minimizes the risk of infectionby minimizing human contact with the intraurethral device.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008]FIG. 1 is a perspective view of an intraurethral device inaccordance with an exemplary embodiment of the present invention;

[0009]FIG. 2 is a side view of an intraurethral device in accordancewith an exemplary embodiment of the present invention;

[0010]FIG. 3 is a perspective view of an intraurethral device inaccordance with an exemplary embodiment of the present invention;

[0011]FIG. 4 is a perspective view of an assembly including an insertiontool and an intraurethral device in accordance with an exemplaryembodiment of the present invention;

[0012]FIG. 5 is a perspective view of an additional embodiment of anintraurethral device in accordance with the exemplary embodiment of thepresent invention; and

[0013]FIG. 6 is a side view of an intraurethral device disposed in theurethra of a patient.

DETAILED DESCRIPTION OF THE INVENTION

[0014] The following detailed description should be read with referenceto the drawings, in which like elements in different drawings arenumbered identically. The drawings which are not necessarily to scale,depict selected embodiments and are not intended to limit the scope ofthe invention.

[0015] Examples of constructions, materials, dimensions, andmanufacturing processes are provided for selected elements. All otherelements employ that which is known to those of skill in the field ofthe invention. Those skilled in the art will recognize that many of theexamples provided have suitable alternatives which may be utilized.

[0016]FIG. 1 is a perspective view of an intraurethral device 20 inaccordance with the present invention. Intraurethral device 20 includesa sheath 22 having a distal portion 26 and a proximal portion 24. Sheath22 also includes a proximal retainer 28 disposed proximate it's proximalportion 24. Proximal retainer 28 serves to prevent distal motion ofsheath 22 into the patient by lying against the urethral labia. Sheath22 includes a sheath wall 32 defining a central lumen 30.

[0017] A flow control valve unit 40 is disposed in lumen 30 of sheath22. Two examples of flow control valve assemblies which are suitable forinclusion in valve housing 40 are described by Kulisz et al. in U.S.Pat. No. 5,437,604 entitled NONSURGICAL INTRAURETHRAL BLADDER CONTROLDEVICE, and U.S. patent application Ser. No. 09/207,821 by Migachyov andentitled VALVE FOR BLADDER CONTROL DEVICE, the disclosure of each beinghereby incorporated by reference. Those of skill in the art willappreciate that other flow control valves may be used in conjunctionwith. intraurethral device 20 without departing from the spirit or scopeof the present invention.

[0018] Proximal region 24 of sheath 22 includes a proximal lock 42having recesses or cavities 44. Recesses 44 are adapted to receive aflange portion 48 of flow control valve unit 40. A distal stop 46 liesin distal region 26 of sheath 22 for arresting the distal movement offlow control valve unit 40. Sheath walls 32 are preferably formed of anelastomeric material such that a tubular flow control valve unitinserted within lumen 30 is partially held in position by a friction fitbetween the elastically stretched sheath walls 32 and the outside wallsof the inserted flow control valve and/or by a medical grade adhesive.

[0019] Intraurethral device 20 also includes a distal member 50 having adistal tip 52 and a proximal portion 54. Proximal portion 54 of distalmember 50 is fixed to distal portion 26 of sheath 22 by a linking means60. In the embodiment of FIG. 1, linking means 60 includes an elastomerhinge 62.

[0020] When no external force is applied to elastomer hinge 62,intraurethral device 20 assumes the position illustrated in FIG. 1.Intraurethral device 20 may be selectively placed in other positions bydeforming elastomer hinge 62. For example, distal member 50 may be urgedinto axial alignment with sheath 22. When intraurethral device 20 is inthe position shown in FIG. 1, distal member 50 serves to preventproximal motion of sheath 22 out of the patient by contacting thebladder floor. Two exemplary positions of distal member 50 are bestillustrated in FIG. 2.

[0021]FIG. 2 is a plan view of intraurethral device 20 with an axiallyaligned position of distal member 50 shown with phantom lines. Theaxially aligned position of distal member 50 is generally designated bythe number 100. In a presently preferred method in accordance with thepresent invention, intraurethral device 20 is urged into position 100 toaid in inserting intraurethral device 20 into a urethra. When noexternal forces are applied, intraurethral device 20 assumes a secondposition 200 as shown in FIG. 2. When intraurethral device 20 assumessecond position 200, distal member 50 serves to prevent proximal motionof sheath 22 out of the patient by contacting the bladder floor. In thispresently preferred method, intraurethral device 20 is inserted into theurethra of a patient until distal member 50 is free to assume a secondposition similar to position 200. Those of skill in the art willappreciate that elastomer hinge 62 may be deformed in varying degrees toachieve any number of second positions of distal member 50.

[0022] In a presently preferred embodiment, sheath 22, distal member 50,and elastomer hinge 62 are all comprised of the same material. Apresently prefer-red method of manufacturing this preferred embodimentis injection molding. Materials which may be suitable for this preferredembodiment include implantable grade silicone rubber, and thermoplasticrubber. Single piece construction simplifies assembly and reduces thepossibility of any device components separating during residence in thepatient

[0023] Embodiments of intraurethral device 20 have also been envisionedwhich include a surface layer 90. Surface layer 90 may include ananti-microbial chemical agent such as chlorhexidine gluconate (CHG) orsilver compounds to reduce the likelihood of infection during use.Surface layer 90 may also include materials such as hyaluronic acid, ahydrogel, or other materials to mimic mucous. Surface layer 90 may alsoinclude a lubricious material such as a hydrophilic hydrogel or ahydrophobic silicone to facilitate insertion and removal. It isenvisioned that one or more of the above described surface layermaterials can be used. Embodiments of intraurethral device 20 have alsobeen envisioned having a distal member 50 and a sheath 22 which arecomprised of a material which includes the materials described above.

[0024]FIG. 3 is a perspective view of intraurethral device 20 withdistal member 50 in axial alignment with sheath 22. In a presentlypreferred embodiment, distal member 50 preferably has a rounded shape toease insertion through the urethra. Also in a presently preferredembodiment, the outer diameter of distal member 50 is substantiallyequal to the outer diameter of sheath 22.

[0025] In a presently preferred method distal member 50 is urged intoposition 100 when inserting sheath 22 into the urethra. This method maynow be described with reference to FIGS. 1, 2, and 3. It should beunderstood that steps may be omitted from this process and/or, thesequence of the steps may be changed without deviating from the spiritor scope of the invention.

[0026] A presently preferred method in accordance with the presentinvention begins with the step of inserting distal member 50 into afemale urethra. Intraurethral device 20 is then urged into position 100as shown in FIGS. 2 and 3. The remainder of intraurethral device 20including sheath 22 may then be urged into the female urethra. In manycases it is desirable to apply a lubricant to the exterior surfaces ofdistal member 50 and sheath 22 prior to insertion. During this insertionstep, the urethra will hold intraurethral device 20 in position 100until distal portion 50 enters the bladder. After distal portion 50 ofintraurethral device 20 enters the bladder, it will be free to assumeposition 200. When intraurethral device 20 assumes first position 200,distal member 50 serves to prevent proximal motion of sheath 22 out ofthe patient by contacting the bladder floor. As mentioned previously,elastomer hinge 62 is biased to place distal portion 50 in firstposition 200.

[0027]FIG. 4 is a perspective view of an assembly including anintraurethral device 20 and an insertion tool 400. Insertion tool 400includes a shaft 402 having a distal end 404 and a proximal end 406. Inthe embodiment of FIG. 4 a distal portion 408 of insertion tool 400 isdisposed in lumen 30 of sheath 22. A lumen 30 (shown in FIG. 1) extendsinto proximal portion 54 of tip 52.

[0028] Proximal portion 54 of distal member 50 is fixed to distalportion 26 of sheath 22 by a linking means 60. In the embodiment of FIG.4, linking means 60 includes an elastomer hinge 62. A distal end 404 ofinsertion tool 400 is disposed in lumen 30 of distal member 50. As shownin FIG. 4, distal member 50 is held in axial alignment with sheath 22 bythe presence of distal end 404 of shaft 402 in lumen 30 of distal member50.

[0029] A method of positioning an intraurethral device 20 into a urethrausing insertion tool 400 may now be described with reference to FIG. 4.A first step desirable in some applications is to pre-lubricate andpre-dilate the urethra of the patient. The use of insertion tool 400begins with the step of inserting distal end 404 of shaft 402 into lumen30 of sheath 22. Distal portion 50 of intraurethral device 20 is thenurged into axial alignment with sheath 22. As a result, lumen 30 ofdistal portion 50 is disposed in axial alignment with lumen 30 of sheath22. Insertion tool 400 may then be urged forward so that distal end 404enters lumen 430 of distal portion 50. The entire assembly may now beheld be grasping shaft 402 of insertion tool 400. When insertion tool400 is disposed within lumen 30 of sheath 22 and distal portion 50 itprovides structural support. The structural support provided byinsertion tool 400 improves the pushability of sheath 22 and distalmember 50. Distal member 50 and sheath 22 may now be inserted into theurethra. In many cases it is desirable to apply a lubricant to theexterior surfaces of distal member 50 and sheath 22 prior to insertion.

[0030] Having placed intraurethral device 20 into the urethra, insertiontool 400 may now be removed from lumen 30 of sheath 22. This may beaccomplished by applying a pulling force on shaft 402 of insertion tool400 while applying a pushing force on proximal retainer 28 ofintraurethral device 20. When insertion tool 400 is removed, distalportion 50 of intraurethral device 20 will be free to assume position200 as shown in FIG. 2. When intraurethral device 20 assumes position200, distal member 50 serves to prevent proximal motion of sheath 22 outof the patient by contacting the bladder floor. Distal motion of sheath22 into the patient is prohibited by proximal retainer 28.

[0031] With sheath 22 and distal member 50 now in the desired position,flow control Valve unit 40 may now be inserted into lumen 30 of sheath22. One method suitable for inserting a flow control valve unit into asheath is described by Pham in U.S. Pat. No. 5,871,016 entitled BLADDERCONTROL DEVICE RETAINER AND METHOD, the disclosure of which is herebyincorporated by reference. This U.S. patent is commonly assigned withthe present application.

[0032] In the foregoing method, shaft 402 of insertion tool 400 providesa convenient location to grasp with the fingers. The use of insertiontool 400 minimizes the risk of infection by minimizing human contactwith intraurethral device 20.

[0033] Other embodiments of insertion tool 400 are possible withoutdeviating from the spirit or scope of the present invention.Specifically, in a presently preferred embodiment, distal end 404 ofshaft 402 is adapted to releasably mate with the proximal end of flowcontrol valve unit 40. A method of inserting an intraurethral device 20in a urethra utilizing this presently preferred embodiment of insertiontool 400 may now be described with reference to FIGS. 1 and 4. Thismethod typically begins with the step of inserting flow control valve 40into lumen 30 of sheath 22. An additional step in this method isreleasably mating the distal end 404 of shaft 402 with the proximal endof flow control valve unit 40. In some instances, it may be desirable toreverse the order of these steps since insertion tool 400 may aid ininserting flow control valve unit 40 into lumen 30 of sheath 22.

[0034] When flow control valve 40 is inserted completely into lumen 30of sheath 22, flange 48 may be inserted into recesses 44. With thedistal end of insertion tool 400 mated to the proximal end of flowcontrol valve unit 40, shaft 402 of insertion tool 400 provides aconvenient location to grasp the assembly. The use of insertion tool 400minimizes the risk of infection by minimizing human contact withintraurethral device 20.

[0035] Shaft 402 of insertion tool 400 may be grasped with thephysicians fingers to begin insertion of intraurethral device 20 isinserted into the urethra. Distal member 50 of intraurethral device 20may then be inserted into the urethra of the patient. Having positioneddistal member 50 in the urethra, intraurethral device 20 is then urgedinto position 100 as shown in FIGS. 2 and 3. The remainder ofintraurethral device 20 including sheath 22 may then be urged into thefemale urethra. During this insertion step, the urethra will holdintraurethral device 20 in position 100 until distal portion 50 entersthe bladder. After distal portion 50 of intraurethral device 20 entersthe bladder, it will be free to assume position 200. When intraurethraldevice 20 assumes first position 200, distal member 50 serves to preventproximal motion of sheath 22 out of the patient by contacting thebladder floor. As mentioned previously, elastomer hinge 62 is biased toplace distal portion 50 in first position 200.

[0036] Once intraurethral device 20 is located in the desired position,the distal end of insertion tool 400 may be disengaged from the proximalend of flow control valve unit 40. Those of skill in the art willappreciate that a number of methods may be used to releasably matedistal end 404 of shaft 402 to the proximal end of the flow controlvalve unit 40. Examples of methods suitable for some applicationsinclude screw threads, a bayonet connection, and an interference fit.

[0037]FIG. 5 is a perspective view of an additional embodiment of anintraurethral device 120 in accordance with the present invention.Intraurethral device 120 includes a sheath 122 having a distal portion126 and a proximal portion 124. Sheath 122 also includes a proximalretainer 128 disposed proximate it's proximal portion 124. Sheath 122includes a sheath wall 132 defining a central lumen 130, providing afluid flow channel from a distal orifice 136 to a proximal orifice 134in proximal region 124.

[0038] A flow control valve unit 140 is disposed in lumen 130 of sheath122. Proximal region 124 includes a proximal lock 142 having recesses orcavities 144. Recesses 144 are adapted to receive a flange portion 148of flow control valve unit 140. A distal stop 146 lies in distal region126 for arresting the distal movement of flow control valve unit 140.Sheath walls 132 are preferably formed of an elastomeric material suchthat a tubular flow control valve unit inserted within lumen 130 ispartially held in position by a friction fit between the elasticallystretched sheath walls 132 and the outside walls of the inserted flowcontrol valve.

[0039] Intraurethral device 120 also includes a distal member 150 havinga distal tip 152 and a proximal portion 154. Proximal portion 154 ofdistal member 150 is fixed to distal portion 126 of sheath 122 by alinking means 160. In the embodiment of FIG. 5, linking means 160includes a leaf spring 500. In a presently preferred embodiment, leafspring 500 is comprised of stainless steel. Those of skill in the artwill appreciate that leaf spring 500 may be comprised of other materialswithout deviating from the spirit and scope of the present invention.

[0040] Intraurethral device 120 assumes the position illustrated in FIG.5, whenever no outside forces are acting upon leaf spring 500.Intraurethral device 120 may be selectively placed in other positions byapplying force to deform leaf spring 500. For example, distal member 150may be urged into axial alignment with sheath 122. When intraurethraldevice 120 is in the position shown in FIG. 5, distal member 150 servesto prevent proximal motion of sheath 122 out of the patient bycontacting the bladder floor. Distal member 150 may be selectivelypositioned in axial alignment with sheath 122.

[0041] In a presently preferred embodiment, distal member 150 and leafspring 500 are fixed together using an over molding process. In the ismanufacturing process, a distal portion of leaf spring 500 is positionedin a mold cavity. The material of distal member 150 is then injectedinto the mold cavity. The material of distal member 150 surrounds distalportion of leaf spring 500. When the material solidifies, it forms abond with distal portion of leaf spring 500. Materials which may besuitable for this preferred embodiment include thermoset materials suchas implantable grade silicone rubber. Materials which may be. suitablefor this preferred embodiment also include thermoplastic materials suchas thermoplastic rubber. Those of skill in the art will appreciate thatother methods of attaching distal portion 502 of leaf spring 500 todistal member 150 may be. used without deviating from the spirit orscope of the present invention. For example, the mechanical attachmentor the use of adhesives may be suitable for some applications.

[0042] In the embodiment of FIG. 5, a proximal portion of leaf spring500 is fixed to sheath 122. A number of methods may be used to attachproximal portion 504 to sheath 122, including over-molding, adhesivebonding, and mechanical attachment. Additional embodiments have beenenvisioned in which proximal portion of leaf spring 500 is fixed to flowcontrol valve unit 140.

[0043] When insertion tool 400 is removed, distal portion 150 ofintraurethral device 120 will be free to assume position 200 as shown inFIG. 2. When intraurethral device 120 assumes position 200, distalmember 150 serves to prevent proximal motion of sheath 122 out of thepatient by contacting the bladder floor. Distal motion of sheath 122into the patient is prohibited by proximal retainer 128.

[0044] Referring now to FIG. 6 there is shown a partial cross-sectionalview representative of a urethra 600 and a bladder 602 of a patient. InFIG. 6 intraurethral device 20 is shown after placement in the urethraof the patient. and after whatever placement devices which were usedhave been removed and the urethra has undilated to closely hold and formto the outer surface of intraurethral device 20. It can be appreciatedthat after intraurethral device 20 is placed in the desired positiondistal portion 50 of intraurethral device 20 assumes a position which isnot in axial alignment with sheath 22. When intraurethral device 20assumes such a position, distal member 50 serves to prevent proximalmotion of sheath 22 out of the patient by contacting the bladder floor.Distal motion of sheath 22 into the patient is prohibited by proximalretainer 28 which contacts the labia of the urethra. In this manner,intraurethral device 20 is held within the urethra by distal member 50and proximal retainer 28 acting at opposite ends of the urethra.

[0045] Having thus described the preferred embodiments of the presentinvention, those of skill in the art will readily appreciate that yetother embodiments may be made and used within the scope of the claimshereto attached.

[0046] Numerous advantages of the invention covered by this documenthave been set forth in the foregoing description. It will be understood,however, that this disclosure is, in many respects, only illustrative.Changes may be made in details, particularly in matters of shape, size,and arrangement of parts without exceeding the scope of the invention.The invention's scope is, of course, defined in the language in whichthe appended claims are expressed.

What is claimed is:
 1. A female intraurethral device for containing aurinary flow control valve unit comprising: a sheath having a distalportion, a proximal portion, and a lumen therethrough; a distal memberhaving a proximal portion; wherein the proximal portion of the distalmember is elastically hinged to the distal portion of the sheath; andthe distal member being biased to extend radially away from the sheath.2. A female intraurethral device as recited in claim 1, wherein the axisof the distal member is disposed at an angle to the axis of the sheath.3. A female intraurethral device as recited in claim 1, wherein thedistal member has a first, outwardly extended position, and second,longitudinally extended position.
 4. A female intraurethral sheath asrecited in claim 1, wherein the sheath, and the distal member are bothcomprised of silicone rubber.
 5. A female intraurethral sheath asrecited in claim 4, wherein the sheath, and the distal member are bothcomprised of thermoplastic rubber.
 6. A female intraurethral device asrecited in claim 1, wherein a flow control valve is disposed within saidsheath lumen.
 7. A female intraurethral device as recited in claim 1,wherein the distal member includes a generally conical distal tip.
 8. Afemale intraurethral device for containing a urinary flow control valveunit comprising: a sheath having a distal portion, a proximal portion,and a lumen therethrough; a distal member having a proximal portion; alinking member having a distal end and a proximal end; the distal end ofthe linking member being fixed to the proximal end of the distal member;and the proximal end of the linking member being fixed to the distal endof the sheath.
 9. A female intraurethral device as recited in claim 1,wherein the linking member is comprised of a flexible material.
 10. Afemale intraurethral device as recited in claim 1, wherein the linkingmember is comprised of an elastomeric material.
 11. A femaleintraurethral device as recited in claim 1, wherein the axis of thedistal member is disposed at an angle to the axis of the sheath.
 12. Afemale intraurethral device as recited in claim 1, wherein the distalmember has a first, outwardly extended position, and second,longitudinally extended position.
 13. A female intraurethral sheath asrecited in claim 4, wherein the distal member and the linking member areintegrally formed with the sheath.
 14. A female intraurethral sheath asrecited in claim 4, wherein the sheath, the distal member, and thelinking member are all comprised of silicone rubber.
 15. A femaleintraurethral sheath as recited in claim 4, wherein the sheath, thedistal member, and the linking member are all comprised of thermoplasticrubber.
 16. A female intraurethral device as recited in claim 1, whereina flow control valve is disposed within said sheath lumen.
 17. A femaleintraurethral device as recited in claim 1, wherein the distal memberincludes a generally conical distal tip.
 18. A method for treatingfemale urinary incontinence comprising the steps of: providing a femaleintraurethral device comprising a flow control valve disposed in asheath and a distal member elastically hinged to a distal portion of thesheath; inserting the distal member into a female urethra; urging sheathinto axial alignment with the distal member; and urging the sheath intothe female urethra.
 19. The method of claim 12, further including thesteps of: providing an insertion tool including a distal end; and fixingthe distal end of the insertion tool to a proximal end of the flowcontrol valve.
 20. The method of claim 12, wherein the axis of thedistal member is disposed at an angle to the axis of the sheath.
 21. Themethod of claim 12, wherein the distal member has a first, outwardlyextended position, and second, longitudinally extended position.